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Q85-88: Toxicity Prophylaxis

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion » Q85-88: Toxicity Prophylaxis

Question 85-86: Therapy given for the prevention of CRS: (prophylactic therapy) Presently, CRS prophylaxis is not routinely performed. However, practices related to CRS are evolving rapidly and some programs have considered using drugs like tocilizumab preemptively in…

Q64-99: Post-HCT / Post-Infusion Planned Therapy

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data » Q64-99: Post-HCT / Post-Infusion Planned Therapy

Question 64: Was therapy given since the date of last report for reasons other than relapse or progressive disease? (Include any maintenance and consolidation therapy.) Indicate if the recipient received treatment post-Infusion for reasons other than relapse,…

Q43-88: Disease Relapse or Progression Post-HCT / Post-Infusion

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion » Q43-88: Disease Relapse or Progression Post-HCT / Post-Infusion

Question 43: Was a disease relapse or progression detected since the date of last report? Refer to the international working group criteria provided in CLL Response Criteria section of the Forms Instructions Manual for more information on how to determine recurrence…

Q83-88: Data from Post-HSCT Follow-Up Form (2100)

Infection & Miscellaneous Manuals » 2540: Tepadina® Supplemental Data » Q83-88: Data from Post-HSCT Follow-Up Form (2100)

Questions 83-88 refer to data reported on form 2100, Q441-615, please ensure data reported here matches with form 2100. Questions 83-85: In the transplant physician’s judgment, were any of the disorders / impairments reported on the form 2100 a direct result of…

Q64-91: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2011: ALL Pre-Infusion » Q64-91: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

All values reported in questions 64-91 must reflect the most recent testing prior to the start of the preparative regimen (or infusion if no preparative regimen was given. Do not report testing performed during a line of therapy reported in questions 20-68. If testing…

2553: VOD/SOS

Infection & Miscellaneous Manuals » 2553: VOD/SOS

The Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome (SOS) Form, Form 2553, must be completed when VOD / SOS has been reported to have developed on the 100 Day Post-HCT Data Form (F2100) or the 100 Day Post-TED Form (Form 2450). Additionally, a Six Month…

2114: Myelodysplastic Syndrome (MDS) Post-Infusion

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2114: Myelodysplastic Syndrome (MDS) Post-Infusion

This form must be completed for all recipients who are randomized to the Comprehensive Report Form (CRF) track and whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as “Myelodysplastic Syndrome (MDS) (50)” The Myelodysplastic…

Q36-82: Organ Function

Infection & Miscellaneous Manuals » 2540: Tepadina® Supplemental Data » Q36-82: Organ Function

Questions 36 – 82: Organ Function This section of the form compliments the organ function section of the Post-HCT Follow Up Data Form, F2100. Hypersensitivity !Questions 36-40 can only be complete on the 100 day follow-up form. These questions will be skipped…

Q69-96: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2010: AML Pre-Infusion » Q69-96: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

All values reported in questions 69-96 must reflect the most recent testing prior to the start of the preparative regimen (or infusion if not preparative regimen was given. Do not report testing performed during a line of therapy reported in questions 33-68. If testing…

2112: CML Post-Infusion Data

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2112: CML Post-Infusion Data

Chronic myelogenous leukemia (CML) is a slow-progressing cancer of the myeloid white blood cells. It is characterized by the increased proliferation of immature white blood cells (granulocytes) with damaged DNA, or blasts, which accumulate in the blood and bone marrow.…

Q86-92: Disease Modifying Therapies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2030: SCD Pre-Infusion » Q86-92: Disease Modifying Therapies

Question 86: Were disease modifying therapies given? (excludes blood transfusions) Indicate if the recipient received disease modifying therapies (see question 87 for a list of common disease modifying therapies) at any time between diagnosis and the start of the…

Q87-104: Post-HCT / Post-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2157: Myeloproliferative Neoplasm (MPN) Post-Infusion » Q87-104: Post-HCT / Post-Infusion Therapy

Question 87: Was therapy given since the date of last report for reasons other than relapsed, persistent, or progressive disease including detection of minimal residual disease or decreased / loss of donor chimerism? (include any maintenance therapy) Indicate if the…

2540: Tepadina® Supplemental Data

Infection & Miscellaneous Manuals » 2540: Tepadina® Supplemental Data

Tepadina® Supplemental post-HCT Data Collection Form, Form 2540, must be completed for recipients who are enrolled onto CIBMTR study SC17-03. This is a multi-center, prospective, observational post-authorization long-term study of the use of thiotepa as part of a…

2010: AML Pre-Infusion

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2010: AML Pre-Infusion

The Acute Myelogenous Leukemia Pre-Infusion Data Form (Form 2010) is one of the Comprehensive Report Forms. This form captures AML-specific pre-infusion data such as: the recipient’s hematologic findings at the time of diagnosis and prior to the start of the…

Q65-91: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2015/2115: Juvenile Myelomonocytic Leukemia (JMML) » 2015: JMML Pre-HCT » Q65-91: Laboratory Studies at Last Evaluation Prior to the Start of the Preparative Regimen

These questions are intended to determine the hematological status of the recipient prior to the preparative regimen. Testing may be performed multiple times within the pre-transplant work-up period (approximately 30 days) prior to the start of the preparative regimen;…

Q85 – 107: Disease Assessment at the Time of Best Response to Infusion

Transplant Essential Data (TED) Manuals » 2450: Post-TED » Q85 – 107: Disease Assessment at the Time of Best Response to Infusion

!Malignant Diseases Only Only complete Disease Assessment at the Time of Best Response to Infusion questions if the HCT being reported was given to treat a malignant disease. If the HCT being reported was given to treat a non-malignant disease, leave these questions…

Q54-109: Organ Parameters of Amyloidosis at the Time of Best Response

Comprehensive Disease-Specific Manuals » 2016/2116: Plasma Cell Disorders (PCD) » 2116: PCD Post-Infusion » Q54-109: Organ Parameters of Amyloidosis at the Time of Best Response

!Complete questions 54-109 for amyloid patients only. If diagnosis was other than amyloidosis or there is no history of it, continue with question 110. The response time for amyloidosis tends to occur well after transplant, so the “best response” to transplant may…

Q75-100: Apheresis Collection

Infection & Miscellaneous Manuals » 2565: Sanofi Mozobil Supplemental Data » Q75-100: Apheresis Collection

Question 75-76: Did the recipient receive blood transfusions (RBCs) during this apheresis collection? Report “Yes” if the recipient received blood transfusions during this apheresis collection. Also, indicate the number of units of RBCs transfused during the…

2113: CLL Post-Infusion

Comprehensive Disease-Specific Manuals » 2013/2113: Chronic Lymphocytic Leukemia (CLL) » 2113: CLL Post-Infusion

The Chronic Lymphocytic Leukemia Post-Infusion Data Form is one of the Comprehensive Report Forms. This form captures CLL-specific post-infusion data such as: disease assessment at the time of best response to HCT or cellular therapy, laboratory studies at the time of…

2011: ALL Pre-Infusion

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2011: ALL Pre-Infusion

The Acute Lymphoblastic Leukemia Pre-Infusion Data Form (Form 2011) is one of the Comprehensive Report Forms. This form captures ALL-specific pre-infusion data such as: the recipient’s hematologic findings at the time of diagnosis and prior to the start of the…

4000: Cellular Therapy Essential Data Pre-Infusion

Cellular Therapy Manuals » 4000: Cellular Therapy Essential Data Pre-Infusion

This form must be completed for all recipients of cellular therapy (non-HCT) with or without a prior HCT. Recipients of CAR T cells, donor lymphocyte infusions, tumor-infiltrating lymphocytes, cytotoxic T cells are common cellular therapies that should be reported…

Q86-103: Additional Drugs Given in the Peri-Transplant Period

Comprehensive Baseline & Follow-up Manuals » 2000: Recipient Baseline » Q86-103: Additional Drugs Given in the Peri-Transplant Period

Drugs may be given during the peri-transplant period to prevent transplant-related complications or facilitate engraftment. Question 86: ALG, ALS, ATG, ATS Anti-Lymphocyte Globulin (ALT), Anti-Lymphocyte Serum (ALS), Anti-Thymocyte Globulin (ATG), or Anti-Thymocyte…

Q73-87: Post-HCT / Post-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2114: Myelodysplastic Syndrome (MDS) Post-Infusion » Q73-87: Post-HCT / Post-Infusion Therapy

Question 73: Was therapy given since the date of last report for reasons other than relapse or persistent disease? (include any maintenance therapy) Indicate if the recipient received treatment post-infusion for reasons other than relapse or persistent disease during…

Q48-94: Disease Detection Since Date of Last Report

Comprehensive Disease-Specific Manuals » 2011/2111: Acute Lymphoblastic Leukemia (ALL) » 2111: ALL Post-Infusion » Q48-94: Disease Detection Since Date of Last Report

!Questions 48-94 This section is intended to capture information only on recipients who relapse, have persistent or minimal residual disease in this reporting period. For questions 48, 54, 61, 71, and 78, report “No” or “Unknown” (see instructions…

Q52-104: Disease Assessment between Diagnosis and the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2034/2134: X-Linked Lymphoproliferative Sydrome (XLP) » 2034: XLP Pre-HCT » Q52-104: Disease Assessment between Diagnosis and the Start of the Preparative Regimen

Question 52: Was HLH present? HLH is an abnormal proliferation of macrophages and histiocytes that leads to the phagocytosis of healthy circulating blood cells. Indicate if the patient developed HLH at any time after diagnosis but prior to the start of the preparative…

Q51-105: Clinical Status of Recipient Post-HCT

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2133: WAS Post-HCT » Q51-105: Clinical Status of Recipient Post-HCT

Question 51: Did the recipient experience any types of bleeding (since the date of last report)? Due to WAS-associated thrombocytopenia, bleeding episodes are frequently observed. Indicate whether the recipient experienced any types of bleeding since the date of last…

Q82-139: Disease Assessment at Transformation

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2018: LYM Pre-Infusion » Q82-139: Disease Assessment at Transformation

!Disease Assessments at Transformation If this a report of a subsequent infusion and: 1. The prior infusion was an autologous transplant that was not reported, and a transformation occurred at any time between diagnosis and the current infusion, complete the Disease…

Q172-236: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2114: Myelodysplastic Syndrome (MDS) Post-Infusion » Q172-236: Disease Status at the Time of Evaluation for this Reporting Period

Question 172: Does the current disease status reflect the disease detected in this reporting period section (as captured in questions 89-152), without subsequent therapy? This section of the form is intended to capture the most recent disease assessments performed in…

Q1-28: Diagnosis

Infection & Miscellaneous Manuals » 2553: VOD/SOS » Q1-28: Diagnosis

Veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS) may occur have HCT as a conditioning regimen injury to the hepatic venous endothelium, resulting in hepatic venous outflow obstruction due to occlusion of the hepatic venules and sinusoids. This…

Q74-100: Other Laboratory Studies

Comprehensive Disease-Specific Manuals » 2030/2130: Sickle Cell Disease (SCD) » 2130: SCD Post-Infusion » Q74-100: Other Laboratory Studies

Questions 74 – 75: Was hemoglobin electrophoresis performed? Indicate if hemoglobin electrophoresis studies were performed since the date of last report. If hemoglobin electrophoresis studies were performed, report Yes and provide the date of the most recent…

2020 Manual Updates

Getting Started » Historical Manual Updates » 2020 Manual Updates

January 2020 February 2020 March 2020 April 2020 May 2020 June 2020 July 2020 August 2020 October 2020 December 2020 Updates made during the current calendar year are included below. For updates prior to 2020, click on the subtopic corresponding to the year of…

Q78-95: Laboratory Findings Prior to the Start of the Preparative Regimen / Infusion

Comprehensive Disease-Specific Manuals » 2028/2128: Aplastic Anemia » 2028: Aplastic Anemia Pre-Infusion » Q78-95: Laboratory Findings Prior to the Start of the Preparative Regimen / Infusion

*Laboratory Findings Prior to the Start of the Preparative Regimen / Infusion: For questions 80 – 97, report all findings within two months prior to the start of the preparative regimen. If the assessment was performed multiple times, report the most recent results…

Q42-130:Clinical Features Assessed between Diagnosis and the Start of the Preparative Regimen

Comprehensive Disease-Specific Manuals » 2033/2133: Wiskott-Aldrich Syndome (WAS) » 2033: WAS Pre-HCT » Q42-130:Clinical Features Assessed between Diagnosis and the Start of the Preparative Regimen

Infections identified between Diagnosis and the Start of the Preparative Regimen Specify the presence of all clinically significant infections identified between diagnosis and the start of the preparative regimen. For the purposes of this form, clinically significant…

Q1 – 141: Disease Assessment at Diagnosis

Comprehensive Disease-Specific Manuals » 2029/2129: Fanconi Anemia / Constitutional Anemia » 2029: Fanconi Anemia / Constitutional Anemia Pre-HCT » Q1 – 141: Disease Assessment at Diagnosis

Question 1: What was the date of diagnosis of Fanconi Anemia? Report the date of first pathological evaluation (e.g., bone marrow biopsy) or blood/serum assessment (e.g., CBC, peripheral blood smear) that determined the diagnosis of Fanconi anemia. Enter the date the…

Q51-103: Disease Detection Since Date of Last Report

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2110: AML Post-Infusion » Q51-103: Disease Detection Since Date of Last Report

!Questions 51-103 This section is intended to capture information only on recipients who relapse, have persistent or minimal residual disease in this reporting period. For questions 51, 63, 70, 80, and 87, report “No” or “Unknown” (see instructions…

Q41-93: Product Analysis (All Products)

Comprehensive Baseline & Follow-up Manuals » 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion » Q41-93: Product Analysis (All Products)

!NOTE: Product Analysis Timepoints Prior revisions of the HCT Product and Infusion (2006) Form (Revisions 1-4) have asked for product analysis values at multiple timepoints. In the new revision of the form, only the “At Infusion” timepoint is required for all…

Q82-156: Pre-HCT / Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2014: Myelodyplastic Syndrome (MDS) Pre-Infusion » Q82-156: Pre-HCT / Pre-Infusion Therapy

The FormsNet3SM application allows questions 83-157 to be reported multiple times. Complete these questions for each line of therapy administered on or after the date of diagnosis of MDS and prior to the start of the preparative regimen (or prior to infusion if no…

Q87 – 120: Comorbid Conditions

Transplant Essential Data (TED) Manuals » 2400: Pre-TED » Q87 – 120: Comorbid Conditions

*Diagnosis of COVID-19 after the start of the preparative regimen: Questions 87 – 89 are intended to capture COVID-19 (SARS-CoV-2) infections diagnosed prior to the start of the preparative regimen / infusion. If a COVID-19 infection is diagnosed after the start of…

Q87-90: Disease Status at the Time of Evaluation for this Reporting Period

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion » Q87-90: Disease Status at the Time of Evaluation for this Reporting Period

Question 87: What is the current disease status? (by CT (radiographic) criteria) Indicate the current disease status, based on radiographic criteria, using the international working group criteria provided in LYM Response Criteria section of the Forms Instruction…

2019 Manual Updates

Getting Started » Historical Manual Updates » 2019 Manual Updates

January 2019 February 2019 March 2019 April 2019 May 2019 June 2019 July 2019 August 2019 October 2019 December 2019 Updates made during the current calendar year are included below. For updates prior to 2019, click on the subtopic corresponding to the year of…

Q3-95: Acute Myelogenous Leukemia

Transplant Essential Data (TED) Manuals » 2402: Disease Classification » Q3-95: Acute Myelogenous Leukemia

Acute Myelogenous Leukemia (AML) is a cancer of the white blood cells. It is characterized by the rapid proliferation of abnormal, immature myelocytes, known as myeloblasts, in the bone marrow. This accumulation of blasts in the marrow prevents the formation of healthy…

2118: LYM Post-Infusion

Comprehensive Disease-Specific Manuals » 2018/2118: Hodgkin and Non-Hodgkin Lymphoma » 2118: LYM Post-Infusion

Complete this form for recipients whose primary disease, reported on the Disease Classification Form (Form 2402), is Hodgkin Lymphoma (HL) or non-Hodgkin Lymphoma (NHL). One exception is Waldenstrom’s macroglobulinemia / lymphoplasmacytic lymphoma, for which, a…

Q44-94: Clinical Features Assessed Post-HCT

Comprehensive Disease-Specific Manuals » 2031/2131: Immune Deficiencies (ID) » 2131: ID Post-HCT » Q44-94: Clinical Features Assessed Post-HCT

Infections Identified Post-HCT Specify the presence of all clinically significant infections identified since the date of the last report. Only report an organism once, even if it was identified at the same site in subsequent infections. Question 44:…

Q88-171: Most Recent Laboratory Studies

Comprehensive Disease-Specific Manuals » 2014/2114: Myelodysplastic Syndrome (MDS) » 2114: Myelodysplastic Syndrome (MDS) Post-Infusion » Q88-171: Most Recent Laboratory Studies

!Questions 88-99 refer to overlap syndromes including CMMoL; JMML; aCML; MDS/MPN-RS-T; MDS/MPN, unclassifiable; if the diagnosis was other than an overlap syndrome, continue with question 100. Questions 88-89: Did the recipient have splenomegaly? Indicate if the…

Q62 – 232: Laboratory Values at Diagnosis of Neuroblastoma

Comprehensive Disease-Specific Manuals » 2026/2126: Neuroblastoma » 2026: Neuroblastoma Pre-Infusion » Q62 – 232: Laboratory Values at Diagnosis of Neuroblastoma

*Laboratory Studies at Diagnosis The intent of questions 62 -232 is to capture the laboratory findings at the time of diagnosis; if multiple studies were performed prior to the institution of therapy, or if time elapsed between diagnosis and treatment, report the…

Q104-144: Disease Status at the Time of Evaluation for This Reporting Period

Comprehensive Disease-Specific Manuals » 2010/2110: Acute Myelogenous Leukemia (AML) » 2110: AML Post-Infusion » Q104-144: Disease Status at the Time of Evaluation for This Reporting Period

Question 104: Does the current disease status reflect the disease detected in this reporting period section (as captured in questions 51-89), without subsequent therapy? This section of the form is intended to capture the most recent disease assessment. The most…

Q84-185: Pre-HCT or Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2012/2112: Chronic Myeloid Leukemia (CML) » 2012: CML Pre-Infusion Data » Q84-185: Pre-HCT or Pre-Infusion Therapy

The FormsNet3SM application allows questions 85-185 to be reported multiple times. Complete these questions for each line of therapy administered prior to the start of the preparative regimen (or prior to infusion if no preparative regimen was given). When submitting…

Q55-212: Pre-HCT / Pre-Infusion Therapy

Comprehensive Disease-Specific Manuals » 2057/2157 Myeloproliferative Neoplasms (MPN) » 2057: Myeloproliferative Neoplasm (MPN) Pre-Infusion » Q55-212: Pre-HCT / Pre-Infusion Therapy

The FormsNet3SM application allows questions 56-211 to be reported multiple times. Complete these questions for each line of therapy administered on or after the date of diagnosis of MPN and prior to the start of the preparative regimen (or prior to infusion if no…

Q81 – 130: Acute Graft vs. Host Disease (GVHD)

Comprehensive Baseline & Follow-up Manuals » 2100: Post-Infusion Follow-Up » Q81 – 130: Acute Graft vs. Host Disease (GVHD)

*Autologous Transplants If this was an autologous infusion or syngeneic, continue with the Infection Prophylaxis section. The graft-versus-host disease sections should only be completed if an allogeneic donor was used. !Acute GVHD Prophylaxis Acute GVHD prophylaxis…

Q80-170: Toxicities

Cellular Therapy Manuals » 4100: Cellular Therapy Essential Data Follow-Up » Q80-170: Toxicities

*Report any observed toxicity or infection that occurs post-infusion in this reporting period, regardless of causality and whether or not treatment was administered. The intent is to capture all toxicities diagnosed after the cellular therapy infusion. Although…

2018 Manual Updates

Getting Started » Historical Manual Updates » 2018 Manual Updates

December 2018 November 2018 October 2018 September 2018 August 2018 July 2018 June 2018 May 2018 April 2018 March 2018 February 2018 January 2018 Updates made during the current calendar year are included below. For updates prior to 2018, click on the subtopic…

2017 Manual Updates

Getting Started » Historical Manual Updates » 2017 Manual Updates

December 2017 November 2017 October 2017 September 2017 August 2017 July 2017 June 2017 May 2017 April 2017 March 2017 February 2017 January 2017 !Hyperlinks Please note, hyperlinks on this page will not work for any manual sections which have been retired and / or…